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A New Birth Weight Prediction in Chinese Population

N

Nanfang Hospital, Southern Medical University

Status

Unknown

Conditions

Birth Weight

Treatments

Diagnostic Test: 2D and 3D ultrasonography

Study type

Interventional

Funder types

Other

Identifiers

NCT03223363
LC2016PY021

Details and patient eligibility

About

To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population.

Full description

A prospective study was performed on single pregnant women in third trimester. Three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. Stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. Estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. The accuracy of the model in predicting fetal birth weight was reassured by validation group.

Enrollment

10,000 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • The inclusion criteria consisted of well-defined gestational age (GA), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2D and 3D ultrasonographic data.

Exclusion criteria

  • The exclusion criteria were equivocal GA, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2D and 3D ultrasonography, and delivery in other institutions.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

10,000 participants in 2 patient groups

Development Group
Experimental group
Description:
Development Group is used to establish the prediction model.2D and 3D ultrasonography are performed in this group. Through statistical analysis we obtain a new model.
Treatment:
Diagnostic Test: 2D and 3D ultrasonography
Validation group
Other group
Description:
Validation Group is used to confirm the efficacy of the prediction model.2D and 3D ultrasonography are performed in this group.Absolute and percentage error are calculated and compared with a common formula to confirm the accuracy of this new model.
Treatment:
Diagnostic Test: 2D and 3D ultrasonography

Trial contacts and locations

1

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Central trial contact

Fang Yang

Data sourced from clinicaltrials.gov

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